Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Prophylaxis of COVID-19 Disease in Health Personnel Dedicated to Patients Care With COVID-19 Disease
- Registration Number
- NCT04521322
- Lead Sponsor
- Ariel Dogliotti
- Brief Summary
Coronaviruses are enveloped viruses with an RNA genome. Carrageenans are sulfate polysaccharides synthesized by red algae. Studies conducted in adults and children with the common cold showed the effectiveness of the use of Carrageenan in nasal spray.
For decades, the antiviral action of Carrageenans has been described in numerous studies with different viruses that infect humans: herpes viruses types 1 and 2, human immunodeficiency virus, human papillomavirus, H1N1 influenza virus, dengue virus, rhinovirus, hepatitis A virus, and enteroviruses. Studies on the dynamics of COVID-19 disease show an intense and rapid pharyngeal multiplication in the first 3-5 days of the onset of symptoms, prior to the onset of pulmonary disease.
Finally, this molecule has shown a viricidal effect against SARS-Cov2 in vitro. All this underscores the potential value of a therapy that inhibits the virus in the rhinopharynx.
- Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled trial assessing the use a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 disease in health-workers.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- physician, nurses, and physical therapist who usually attend hospitalized COVID19 patients.
- No more than 48 hours since he/she assisted a COVID-19 patient
- Able to understand and give written informed consent
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Not having a cell phone with WhatsApp for remote monitoring
- Hypersensitivity or known allergy to any component of the product
- Pregnancy or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Iota-Carrageenan Participants in this arm will receive a nasal spray with Iota-Carrageenan Control Iota-Carrageenan Participants in this arm will receive a nasal spray with placebo
- Primary Outcome Measures
Name Time Method diagnose of COVID19 disease 28 days COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test
- Secondary Outcome Measures
Name Time Method lasting of disease 28 days number of days with clinical symptoms
Progression to a more severe disease state, defined as need for oxygen therapy. 28 days number of subjects who develop severe COVID19 disease
Incidence of COVID-19 disease onset in the first week after treatment 1 week after finishing treatment number of subjects who develop the disease within one week after finishing treatment
Trial Locations
- Locations (1)
centro de educación médica e investigaciones clinicas (CEMIC)
🇦🇷Buenos Aires, Capital Federal, Argentina